VASKOTASIN table. 35 mg

Qualitative and quantitative composition:

Each tablet contains 35 mg trimetazidin dihydrochloride.

Excipients with known activity:

Each tablet contains 2,39 mmol sodium.

Pharmaceutical form:

Modified-release tablet.

White to off-white, round, biconvex, film-coated tablets, plain on both sides, on one side.

Clinical data:

Indications

Trimetazidin is indicated in adults as adjunctive treatment for the symptomatic relief of stable angina inadequately controlled antidysrrhytmic main first-line therapy or in patients who are intolerant to such therapy.

Dosage and administration:

Method of application:

Oral.

Dosage:

The dose is one tablet of 35 mg trimetazidin twice daily with meals.

Special Populations:

Patients with renal impairment

In patients with moderate renal impairment, the recommended dose is one 35 mg tablet in the morning during breakfast.

Elderly

Elderly patients may have increased exposure to trimetazidin due to age-dependent decrease in renal function. In patients with moderate renal impairment, the recommended dose is one 35 mg tablet in the morning during breakfast. Titration in elderly patients should be undertaken with caution.

Paediatric population

Safety and efficacy of trimetazidin in children under the age of 18 years established. No data available.

Contraindications:

 Hypersensitivity to the active substance or to any of the excipients.

 Parkinson's disease, symptoms of Parkinson's disease, tremor, restless legs syndrome and other movement disorders

 Severe renal impairment

Special warnings:

Vaskotasin is not indicated for the management of angina attacks, and the initial treatment of unstable angina or myocardial infarction. This medicinal product must not be used before and during the first days of hospitalization.

In case of an attack of angina is necessary to re-examine the coronary vessels and discuss the adaptation of treatment.

Trimetazidin may cause or worsen symptoms of Parkinson's disease, which should be regularly checked, especially in elderly patients. In case of doubt, the patient should be given to a neurologist for appropriate research.

The occurrence of movement disorders as symptoms of Parkinson's disease, restless legs syndrome, tremor, gait instability should lead to outright discontinuation trimetazidin.

These cases have a lower frequency and are usually reversible upon discontinuation of therapy. The majority of patients recover within four months after discontinuation of trimetazidin.

It is possible to observe the falls associated with gait instability or hypotension, particularly in patients receiving antihypertensive therapy.

Caution should be exercised when prescribing trimetzidin in patients who are expected increased exposure:

 Moderate renal impairment

 The elderly, older than 75 years.

Interaction with other medicinal products and other forms of interaction:

There have been reports of drug interactions. Trimetazidin can be administered in combination with heparin, kaltsiparin, vitamin K antagonists, oral hipolipidemichni agents, aspirin, beta-blockers, calcium channel blockers and digitalis drugs.

Pregnancy

Animal studies have shown no teratogenic effects. But due to lack of clinical data, the risk of malformations can not be ruled out. Therefore, for security reasons, the appointment of the product during pregnancy should be avoided.

Lactation

Due to lack of data, breastfeeding is not recommended during treatment with Vaskotasin.

Effects on ability to drive and use machines

Vaskotasin no haemodynamic effects in clinical trials, although the incidence of dizziness and somnolence in post-marketing experience, which may affect the ability to drive and use machines.

Adverse reactions:

Nervous system disorders:

Common - dizziness, headache.

Uncommon - Symptoms of Parkinson's disease, unstable gait, restless leg syndrome, similar disorders, usually reversible upon discontinuation of therapy.

Not known - Sleep Disorders

Cardiac disorders:

Rare - Palpitations, extrasystoles, tachycardia

Vascular disorders:

Rare - hypotension, postural hypotension which may be associated with malaise, dizziness or falls, especially in patients taking antihypertensive therapy, flushing.

List of excipients

Core:

Sodium chloride, povidone, magnesium stearate

Tablet coating:

Cellulose acetate, hypromellose

Special precautions for storage:

This medicinal product does not require any special storage conditions.